Skin rejuvination resurfacing device

ABSTRACT

A skin rejuvenation resurfacing apparatus comprising an oscillating, reciprocating high speed, non-thermal, needle-based device for inducing mechanical trauma to an area of the skin to be treated.

RELATED APPLICATION

This application is a continuation application of nonprovisionalapplication Ser. No. 11/315,841 filed Dec. 22, 2005.

FIELD OF THE INVENTION

The invention relates to a punctile device in the field of aesthetic andreconstructive medicine and cosmetic surgery to enhance the appearanceof skin wrinkles, skin texture and scars.

BACKGROUND OF THE INVENTION

The device and the procedure with which the device is used and referredto herein using punctile resurfacing was developed as a safe andeffective skin rejuvenation system for the improvement of moderatewrinkles, scars, pores, pigmentation and skin texture.

In the aesthetic industry there are many procedures using devices thatimprove the appearance of the skin. These devices can be divided intolaser, broad band light, mechanical and radiofrequency systems.

Lasers use specific wavelengths of light that penetrate the skin, bindto specific chromophores and, through a process called selectivephotothermolysis remove various colors and pigments from the skin. Otherlasers with longer wavelengths of light enter the skin, causenonspecific heating and improve the texture and fine wrinkling of theskin. Intense pulse light systems release many wavelengths of light atonce and also improve the color and texture of the skin throughselective photothermolysis. RadioFrequency technologies, use electricalcurrent to heat the dermis (undercarpet of the skin) and stimulate someproduction of collagen and elastin Fibers that firm and tighten theskin. More ablative technology, CO₂ and Erbium laser resurfacing,chemical peels, plasma resurfacing and mechanical dermabrasion removethe outer layers of the skin, in a relatively precise fashion andthrough the natural healing process, new collagen and elastin isproduced in the skin, improving wrinkles and texture.

Pin point, segmental or fractional injuries to the skin and dermis canbe delivered by laser systems such as Fraxel™, which sends small beamsof erbium glass laser wavelengths into the dermis or the Medical RollCIT™, which is a hand held roller with widely spaced needles. Theadvantage of these segmental, fractional injury and puncturingprocedures, is the dermis is stimulated with either a heat or mechanicaltrauma and the inflammatory response results in dermal remodeling andthe production of new collagen, elastin and ground substance andultimately, skin enhancement and rejuvenation.

The development of the device described herein and the punctileremodeling procedure was designed to deploy, through the proven efficacyof the fractional approach to dermal injury, remodeling and rejuvenationwith a precision, high speed, mechanical needle puncture system andprocedure that would safely and effectively improve the texture andappearance of skin with out the need for laser heating.

Industry and Device Comparisons Monochromatic Lasers:

These devices use specific wavelengths of light that penetrate the skin,bind to specific chromophores and, through a process called selectivephotothermolysis, remove various colors and pigments from the skin. Thelasers are large, expensive pieces of capital equipment, only attackspecific problems or colors in the skin, are prone to laser bums, scars,can cause hyper and/or hypopigmentation and may result in user andpatient ocular injuries.

Intense Broad Band Light Systems:

These systems emit multiple wavelengths of light, and through selectivephotothermolysis, also improve skin discoloration and, through skinheating, non-specific skin texture improvement. The systems are alsolarger and expensive, the skin textures and wrinkle improvements areminimal and there is also the risk of skin bums, hypo orhyperpigmentaiton and scars.

RadioFrequency Devices:

RadioFrequency technologies, use electrical current to heat the dermis(undercarpet of the skin) and stimulate some production of collagen andelastin fibers that firm and tighten the skin. The devices arerelatively expensive, have only modest skin texture or wrinkleimprovements, being more designed for modest skin tightening. There isalso a risk of localized fat necrosis, with permanent dimpling, damageto sensory nerves and scarring.

Plasma Technology:

Plasma technologies use saline and electrical current to induce a thinburn on the outer surface of the skin, inducing a dermal injury whichheals with increase collagen, elastin and dermal ground substance.Although these devices do produce a good improvement in wrinkles, skintightening and texture, they are expensive pieces of capital equipmentand also run the risk of scarring, hyper or hypopigmenation. Therecovery from the procedure is characterized by oozing and discharge andpatients are not ready for make up for 2 weeks.

Laser Resurfacing and Chemical Peel:

Carbon Dioxide or Erbium lasers are used to burn off the outer layer ofskin inducing a thermal injury in the dermis which heals by remodelingand increased collagen and elastin production. Resurfacing lasers alsoproduce good wrinkle and texture improvements with skin tightening, butare expensive can potentially cause scars and profound hypopigmentaionand ocular injury and blindness to the user and the patient. Therecovery from the procedure is characterized by oozing and discharge andpatients are not ready for make up for 2 weeks.

Fraxel Laser:

Is a fractional dermal injury system that functions by emitting beams oferbium glass laser energy that creates multiple small holes in thedermis, alongside uninjured skin. The fractional dermal injury resultsin the remodeling without the significant recovery. The fraxel laser isexpensive, and has modest results at best.

Medical Roll CIT:

This is also a fractional dermal injury system. It is a hand held rollerwith needles mounted on the roller. It is passed repeatedly by handacross the skin creating a dermal injury but leaving a large portion ofthe epidermis intake. There is some bruising and swelling, but verylittle pain, weeping or oozing. The mechanical injury to the dermisresults in some structural collagen and elastic, smoothening out finewinkles. The needles are very long and widely spaced and the patientsexperience a significant amount of discomfort due to the length of theneedle. The hand held nature of the device, make predictable spacing ofthe segmental injury imprecise.

What is needed is a procedure using a Pixelatory™ and PunctileResurfacing device. The inventor herein has developed a more efficient,fast, predictable and less painful device and procedure than the abovedescribed Medical Roll CIT device and its procedure. The presentinventive using the inventor's developed Pixelator™ device provides fora resulting dermal remodeling that improves fine to moderate wrinkles,pigmentation and obtains skin texture improvement. Because there is nolaser or thermal component to the injury, there is very little risk ofhypopigmentation or scarring.

SUMMARY OF THE INVENTION

The present invention is a procedure and apparatus using a foot pedalcontrolled power source, that sends electrical energy to a reciprocatinghand piece, that is, a hand piece that contains the equipment thatcauses the reciprocating and oscillating action of the device. Thereciprocating hand piece provides the rapid oscillating, reciprocatingback and forth (“in and out”) motion of the needle tips. The tip of thereciprocator device has a screw on tip to which the needle tip attaches.

The working tip of the Pixelator™ reciprocator or needle-based device isthe needle tip. It is a series of a number of needles in a desiredarray, typically 12 needles, two rows of 6 needles affixed in arectangle, to a long stainless steel shaft and it screws onto the tip ofthe handpiece or headpiece. Other needle arrays are contemplated such as8 needles up to 16 needles, with different configurations to the needletips themselves.

The needle tip while reciprocating in and out rapidly will have sometoggle and to prevent this, a sheath is inserted over the needle tip anda disposable plastic tip protector is inserted inside the sheath. Theplastic tip can be pushed in or withdrawn to expose more or less of theneedle tip. Thus, the plastic tip controls the depth of penetration.

The Pixelator™ needle-based device is a skin rejuvenation device thatworks on the principle of fractional dermal injury, but induced througha high speed, non-thermal, needle based mechanical trauma. Once theMidas headpiece is assembled, the plastic tip protector is advanced inor out of the sheath to set the length of the punctile needles that willbe exposed to the skin during the treatment, providing a controllable“depth gauge” for the depth of dermal injury.

Anesthesia: The patient is usually anesthetized with local anesthesia.The upper and lower lips, lower eyelids, frown line region and any areaof acne scarring can by infiltrated with local anesthesia and treated.

Punctile Resurfacing: The hand piece and tip is placed over the skinwith direct contact of the needle tip with the skin. By depressing thefoot pedal, the 40 Hz reciprocating oscillations (“in and out” motionsof the needle tip) begin and with each reciprocation the needlespenetrate into the dermis, according to the depth that was set on by theadjustment of the plastic tip protector. The Pixelator™ hand piece isthen passed in one direction across the whole surface area to betreated. The movements are gentle but fast and move in one direction.Once one pass of the entire treatment area has been completed the handpiece and needle tip are then passed in the opposite direction, about 90degrees to the first pass. Once this pass is completed a third pass ismade 90 degrees to the previous pass. With this criss-crossing pattern,up 6-9 passes may be made in each treatment zone. With each pass thereis a small amount of pin-point bleeding, which stops very quickly, dueto the fractional nature of the injury and the presence of bridgingepthermal skin segments. Most of the trauma is dermal and ecchymosis(bruising) is induced under the skin. It is the post dermal inflammationthat will determine the level of new dermal substrate formation. Aftereach pass, the small amount of blood residual on the surface is wipedoff, clotting occurs very quickly and the next pass initiated.

Punctile Resurfacing End Point: After about 6-9 criss-crossing passes onthe skin, there will be a deep bruised discoloration to the skin andedema. Once the ecchymotic, bruised discoloration and edema haseliminated or greatly reduced the wrinkle, scar or textural abnormalityand the color of the dermal bruise is dark blue, the end point oftreatment has arrived. Generally an upper lip or lower lid sized zonetakes 10 minutes to reach the therapeutic end point.

Post-Punctile Resurfacing Care: As punctile resurfacing is a fractionalinjury, there is a microscopic but substantial area of the epidermisthat is intact. The intact epidermis affects a very rapid hemostaticeffect and re-epithelialization repair. As a consequence, the patientspunctile resurfacing area, although bruised in appearance, exhibitsminimal oozing and discomfort as the superficial epidermis isre-epithelialize within 24-48 hours. Cleansing with water and a topicalemollient, such as Polysporin™ ointment is the only after care.

Punctile Resurfacing Results: Over the 6-12 weeks post-punctileresurfacing, the bruising and edema resolves in 4-5 days and the patientmay wear makeup. By 3-4 months, the mechanical trauma and inflammationthat was induced by the fractional needle punctures has induced and postinflammatory reaction resulting in new dermal collagen, elastin andground substance production. The clinical results are smoother wrinkles,improvement in depressed scars, pores, brown discoloration and enhancedskin texture.

Features of the Pixelator™ needle-based device that are used and/orbeneficial in the novel procedure are the more closely spaced needleconfiguration for more precise fractional dermal injury, thereciprocating mechanical handpiece for more rapid and predictabletreatment of areas, the adjustable tip for more control over the depthof the dermal injury, the hand held, comfortable, light and 110-volt outof the wall power source (although DC current is also contemplated), thedisposable needle tip and plastic tip guide, the device headpiece andsheath can be reused, the low cost of operation, the fact that theprocedure does not use a laser device, making it safer for the operatorand patient, and that there is little risk of scars or hypopigmenationas Pixelator™ needle-based device causes a non-thermal mediated injury.

The inventive procedure is a skin rejuvenation resurfacing procedurecomprising performing a punctile resurfacing procedure using anoscillating, reciprocating high speed, non-thermal, needle-based devicefor inducing mechanical trauma to an area of the skin to be treated.

A desired number of passes are made over the surface area of the skin tobe treated in a criss-crossing pattern until there is a deep bruiseddiscoloration and edema to the area of the skin being treated such thata wrinkle, scar or textural abnormality being treated has beeneliminated or greatly reduced.

After the procedure is completed using the needle-based device, the areaof the skin treated is cleansed and a topical emollient is applied.

The resultant bruising and edema resolves in 4-5 days such that make-upmay be worn on the treated area, and the mechanical trauma andinflammation that was induced by fractional needle punctures and thepost inflammatory reaction results in new dermal collagen, elastin andground substance production thereby resulting in smoother wrinkles,improvement in depressed scars and enhanced skin texture.

Prior to starting the resurfacing treatment, the patient being treatedis anesthetized with local anesthesia to the area of the skin to betreated.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying drawings:

FIG. 1 is a schematic depiction of one example of the major systemcomponents used in the inventive procedure;

FIG. 2A is a cross-sectional view of the needle tip area;

FIG. 2B is an end view of the needle tip area of FIG. 2A;

FIG. 3 is a depiction of a typical needle, needle tip sheath and needletip plastic protector;

FIG. 4A is a depiction of the end of the needle tip area being directedin a path with the needles in a partially retracted position; and

FIG. 4B is a depiction similar to FIG. 4A with the needles in anextended position.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, FIGS. 1, 2A, 2B, 3, 4A and 4B disclose anexample of the major system components used in the inventive procedure.Reference to these components will be made in describing the inventiveprocedure.

The invention is a skin rejuvenation resurfacing procedure and itsassociated apparatus wherein a punctile resurfacing procedure isperformed on a subject patient using an oscillating, reciprocating highspeed, non-thermal, needle-based device 12 for inducing mechanicaltrauma to an area of the skin to be treated. Prior to commencing theprocedure, the patient being treated is anesthetized with localanesthesia to the area of the skin to be treated.

A desired number of passes are made over the surface area of the skin tobe treated in a criss-crossing pattern until there is a deep bruiseddiscoloration and edema to the area of the skin being treated such thata wrinkle, scar or textural abnormality being treated has beeneliminated or greatly reduced.

The skin area to be treated is treated using the needle-based device 12by passing in a first direction. Then an alternating pass is done in agenerally criss-crossing pattern to the first direction and thetreatment is repeated in this alternating criss-crossing pattern. Thetypical desired number of passes made over the area of the skin to betreated in the criss-crossing pattern is six to nine passes in eachdirection of the criss-crossing pattern.

After this step is completed, the area of the skin treated is cleansedand a topical emollient, such as Polysporin™ anti-bacterial ointment isapplied.

The resultant bruising and edema resolves in 4-5 days such that make-upmay be worn on the treated area, and the mechanical trauma andinflammation that was induced by fractional needle punctures and thepost inflammatory reaction results in new collagen, elastin and groundsubstance production thereby resulting in smoother wrinkles, improvementin depressed scars, lessened pigmentation and enhanced skin texture.

The needle-based device 12 is a hand-held device and is the power iscontrolled by a hands-free means. For example, a foot pedal or footcontrol switch 16 is typically used in the control circuit between apower controller source 14 and the hand-held needle-based device 12. Thepower controller source is depicted in FIG. 1 as being powered by analternating current source but alternatively could be powered by adirect current source.

The needle-based device includes needle depth adjustment means forobtaining a desired skin penetration depth of needle tip 12 b of aplurality of needles 12 d for the appropriate treatment of the area ofthe skin being treated. The plurality of needles 12 d are preferablyarranged in an array comprising between eight to sixteen needles. Forexample, FIG. 2 b depicts an array of 12 needles arranged in a 2×6configuration.

The needle-based device 12 comprises a hand-held portion 12 a housingmeans for oscillating and reciprocating an elongate needle portion 12 b.This a commercially available hand piece, also referred to as headpiece, which houses the motor and oscillating means (not shown) and towhich the elongate needle portion 12 b is connected at one end and inmechanical communication with the means for oscillating andreciprocating said needle portion 12 b. Typically, the needles 12 doscillate/reciprocate at about 40 cycles per second to about 100 cyclesper second.

As mentioned above, the elongate needle portion 12 b has at its oppositeend, a plurality of needles 12 d configured in a desired array, such as2×6.

A needle sheath 12 c is provided to slide over the needle portion 12 band attach to the hand piece 12 a. The attachment can be by threadedmeans or other methods known in the art. Sheath 12 c generally coversthe elongate needle portion 12 b and is connected to the hand-handportion 12 a and ends with the array of the plurality of needles 12 d.The needle sheath 12 c further serves as means for preventing a side toside movement of the elongate needle portion 12 b.

A needle tip protector 12 e is attached over the plurality of needles 12d and is slidably operable over the plurality of needles 12 d forserving as the needle depth adjustment means for obtaining the desireddepth of needle penetration of said needle tips to the skin area beingtreated. Typically, the protector is slidably engaged with the end ofthe sheath 12 c and is pushed into or pulled away from the end of thesheath 12 c so that when the needle tips are extended at the maximumreciprocation distance away from hand piece 12 a, the distance betweenthe tips and the protector edge equates to the maximum penetration depthdesired to accomplish the desired treatment.

It should be understood that the preceding is merely a detaileddescription of one or more embodiments of this invention and thatnumerous changes to the disclosed embodiments can be made in accordancewith the disclosure herein without departing from the spirit and scopeof the invention. The preceding description, therefore, is not meant tolimit the scope of the invention. Rather, the scope of the invention isto be determined only by the appended claims and their equivalents.

1. An apparatus for use in a skin rejuvenation resurfacing procedurecomprising: a non-thermal needle base device configured for inducing amechanical trauma transdermally into the epidermis, dermis andsubcutaneous fat; means for oscillating and reciprocating at a highspeed an elongated needle portion of said needle-based device and meansfor operating said needle based device at about 40 cycles per second to100 cycles per second to induce a purposeful full skin thickness injuryand inflammatory response that leads to collagen, elastic and groundsubstances to resurface a patient's skin; the needle-based deviceincluding needle depth adjustment means for obtaining a desiredtransdermal penetration needle tip depth sufficient to penetrate throughsaid epidermis, dermis and into said subcutaneous fat of needle tips ofa plurality of needles for the appropriate treatment of the area of theskin being treated; and the needle-based device further comprising: ahand-held portion comprising means for oscillating and reciprocating anelongated needle portion, the elongated needle portion being connectedat one end to said hand-held portion and in mechanical communicationwith said means for oscillating and reciprocating said needle portion,the elongated needle portion having at its opposite end, the pluralityof needles configured in a desired array.
 2. The apparatus according toclaim 1, wherein the needle-based device is a hand-held, mechanicaldevice and is controllable by hands-free means.
 3. The apparatusaccording to claim 2, wherein the hands-free means for controlling theneedle-based device is a foot control switch between a power controllersource and the hand-held needle-based device.
 4. The apparatus accordingto claim 1, wherein the plurality of needles are arranged in an arraycomprising between eight to sixteen needles.
 5. The apparatus accordingto claim 1, wherein the needle-based device further comprises: a needlesheath generally covering said elongate needle portion and connected tothe hand-hand portion and ending near the plurality of needles, saidneedle sheath further serving as means for preventing a side to sidemovement of the elongate needle portion; and a needle tip protectorattached over the plurality of needles, said needle tip protector beingslidably operable over the plurality of needles for serving as theneedle depth adjustment means for obtaining the desired depth of needlepenetration of said needle tips to the skin area being treated.
 6. Theapparatus according to claim 5, wherein the plurality of needles arearranged in an array comprising between eight to sixteen needles.
 7. Theapparatus according to claim 6, comprising twelve needles.